megestrol acetate
Pharmaranks rates Megestrol Acetate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Megestrol Acetate is a progestin used to treat Anorexia, Breast Neoplasms, Cachexia, Endometrial Neoplasms.
Progestin · by Novitium Pharma
Generic of Megace
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Megestrol Acetate
- Drug class
- Progestin
- Form
- Tablet, Suspension
- Strength
- Megestrol Acetate 40MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- anorexia, breast neoplasms, cachexia
- Manufacturer
- Novitium Pharma
- What the pharmacy pays
- ~$7.14 for 30 — not your price
- FDA application
- ANDA077404
What is Megestrol Acetate?
From the FDA label:Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.52. The chemical formula is C 24 H 32 O 4 and the structural formula is represented as follows: Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: citric acid, lemon-lime flavor (propylene glycol, ethyl alcohol, natural flavor), propylene glycol, purified water, sodium benzoate, sodium citrate, sucrose and xanthan gum. Image 1
How to use
Megestrol Acetate is sold in more than one form (Tablet and Suspension), and each is dosed differently. The instructions below come from the FDA label for application ANDA077404 — follow the label that came with the product you were actually prescribed.
The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/day). Shake container well before using. In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.
Side effects
Clinical Adverse Events Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing megestrol acetate oral suspension. ADVERSE EVENTS % of Patients Reporting Megestrol Acetate, mg/day No. of Patients Trial 1 (N=236) Trial 2 (N=87) Open Label Trial Placebo 0 N=34 100 N=68 400 N=69 800 N=65 Placebo 0 N=38 800 N=49 1200 N=176 Diarrhea 15 13 8 15 8 6 10 Impotence 3 4 6 14 0 4 7 Rash 9 9 4 12 3 2 6 Flatulence 9 0 1 9 3 10 6 Hypertension 0 0 0 8 0 0 4 Asthenia 3 2 3 6 8 4 5 Insomnia 0 3 4 6 0 0 1 Nausea 9 4 0 5 3 4 5 Anemia 6 3 3 5 0 0 0 Fever 3 6 4 5 3 2 1 Libido Decreased 3 4 0 5 0 2 1 Dyspepsia 0 0 3 3 5 4 2 Hyperglycemia 3 0 6 3 0 0 3 Headache 6 10 1 3 3 0 3 Pain 6 0 0 2 5 6 4 Vomiting 9 3 0 2 3 6 4 Pneumonia 6 2 0 2 3 0 1 Urinary Frequency 0 0 1 2 5 2 1 Adverse events which occurred in 1% to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol…
Warnings
Important safety information
Megestrol acetate may cause fetal harm when administered to a pregnant woman. For animal data on fetal effects, (see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility: Impairment of Fertility ). There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Megestrol acetate is not intended for prophylactic use to avoid weight loss. (See also PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility ) The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing’s Syndrome have been reported in association with the chronic use of megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealed the frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol acetate therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol acetate therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic megestrol acetate therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (e.g., surgery, infection).
Who should not take Megestrol Acetate
History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.
Overdose — what happens if you take too much
No serious unexpected side effects have resulted from studies involving megestrol acetate oral suspension administered in dosages as high as 1200 mg/day. In post-marketing experience, limited reports of overdose have been received. Signs and symptoms reported in the context of overdose included diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. There is no specific antidote for overdose with megestrol acetate oral suspension. In case of overdose, appropriate supportive measures should be taken. Megestrol acetate has not been tested for dialyzability; however, due to its low solubility, it is postulated that dialysis would not be an effective means of treating overdose.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Pharmacokinetic studies show that there are no significant alterations in pharmacokinetic parameters of zidovudine or rifabutin to warrant dosage adjustment when megestrol acetate is administered with these drugs. The effects of zidovudine or rifabutin on the pharmacokinetics of megestrol acetate were not studied. Megestrol acetate may interact with warfarin and increase International Normalized Ratio (INR). Closely monitor INR in patients taking megestrol acetate and warfarin. Animal Toxicology Long-term treatment with megestrol acetate may increase the risk of respiratory infections. A trend toward increased frequency of respiratory infections, decreased lymphocyte counts, and increased neutrophil counts was observed in a two-year chronic toxicity/carcinogenicity study of megestrol acetate conducted in rats.
Drug class
How this class works, per Progestins - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Megestrol Acetate ranks — best-rated progestin for:
Dosage forms
Tablet and Suspension
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Megestrol Acetate treat?
- Megestrol Acetate (Megestrol Acetate) may be used to treat anorexia, breast neoplasms, cachexia, endometrial neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Megestrol Acetate work?
- Megestrol Acetate is a progestin. Progestins are lab-made versions of the hormone progesterone. Acting through progesterone receptors, they quiet the brain signals that trigger ovulation, thicken cervical mucus so sperm cannot pass, and thin the uterine lining, which together help prevent pregnancy and regulate periods.
- How is Megestrol Acetate rated?
- pharmaranks gives Megestrol Acetate a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Megestrol Acetate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $7.14 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Nor-Qd — about $2.83 on the same basis.
- Is there a coupon or discount for Megestrol Acetate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Megestrol Acetate. To pay less, Megestrol Acetate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Megestrol Acetate?
- Megestrol Acetate is marketed by Novitium Pharma. You can see Novitium Pharma's full profile, rating, and other products on pharmaranks.
- Is Megestrol Acetate a brand-name or generic drug?
- Megestrol Acetate is a generic medication; its active ingredient is Megestrol Acetate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Megestrol Acetate available over the counter?
- No. Megestrol Acetate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Megestrol Acetate come in?
- Megestrol Acetate is currently marketed as tablet and suspension, per the FDA's National Drug Code Directory.
- What class of drug is Megestrol Acetate?
- Megestrol Acetate is classified as progestin, per the FDA's Established Pharmacologic Class.
- Is Megestrol Acetate FDA-registered?
- Megestrol Acetate is on record with the U.S. FDA under application number ANDA077404. You can verify this on its official FDA label.
- Has Megestrol Acetate been recalled by the FDA?
- Megestrol Acetate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Megestrol Acetate safe?
- There's no single safe-or-not verdict. pharmaranks gives Megestrol Acetate a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Megestrol Acetate?
- Megestrol Acetate's side effects are taken directly from its FDA label. From the label: Clinical Adverse Events Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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